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Clinical Trials in the USA / NCT06898957
Active, not recruiting Phase 1

Study of Tarlatamab in Combination With YL201 With or Without Anti-programmed Death Ligand 1 (PD-L1) in Participants With Extensive Stage (ES) Small Cell Lung Cancer (SCLC)

NCT06898957 · tracked via the Priya Life Science USA tracker
Sponsor
Amgen
Phase
Phase 1
Started
2025-05-16
Last updated
2026-05-20

Condition(s) studied

Small Cell Lung Cancer

Investigational drug(s) / intervention(s)

YL201TarlatamabDurvalumab

YL201: YL201 will be administered as an IV infusion.

Tarlatamab: Tarlatamab will be administered as an IV infusion.

Durvalumab: Durvalumab will be administered as an IV infusion.

Study summary

The primary objective of this study is to evaluate the safety and tolerability of tarlatamab in combination with YL201 with or without anti-PD-L1.

Eligibility

Sex
ALL
Min age
18 Years
Max age
99 Years
Healthy volunteers
No
Inclusion Criteria: * Participants ≥ 18 years of age (or legal adult age within country) at time of signing informed consent. * Participants with histologically or cytologically confirmed ES-SCLC. * For Parts 1 and 2, subjects must have ES-SCLC that has progressed or recurred following at least 1 prior line of platinum-based anti-cancer therapy received either for LS-SCLC or ES-SCLC. * For Part 3, subjects must have ES-SCLC and no prior systemic treatment for ES SCLC other than 1 cycle of platinum-based chemotherapy, and etoposide, and with or without PD-(L)1 inhibitor in the first-line setting. * At least 1 measurable lesion as defined by RECIST 1.1. * Participants must have adequate organ function (cardiac, pulmonary, kidney, bone marrow, and liver). Exclusion Criteria: * Prior delta-like ligand 3 (DLL3) or B7 homolog 3 (B7-H3) targeted therapy. * Prior exposure to topoisomerase I inhibitors or antibody-drug conjugate (ADC) with topoisomerase I inhibitor payload. * Symptomatic central nervous system (CNS) metastases. Note: Participants with asymptomatic brain metastases are eligible as defined in the protocol. * History of (non-infectious) interstitial lung disease (ILD)/pneumonitis that required corticosteroids, current ILD/pneumonitis, or suspected ILD/pneumonitis that cannot be ruled out by imaging at screening. * Baseline requirement of supplemental oxygen.

Primary outcome measure(s)

Trial sites (36)

FacilityCityRegionStatus
City of Hope Orange County Lennar Foundation Cancer Center Irvine California
Yale New Haven Hospital New Haven Connecticut
Moffitt Cancer Center Tampa Florida
Dana Farber Cancer Institute Boston Massachusetts
Siteman Cancer Center St Louis Missouri
Sanford Roger Maris Cancer Center Fargo North Dakota
Cleveland Clinic Foundation Cleveland Ohio
Sanford Oncology Clinic and Pharmacy Sioux Falls South Dakota
University of Texas MD Anderson Cancer Center Houston Texas
Swedish Medical Center Seattle Washington
Fred Hutchinson Cancer Center Seattle Washington
CHU de Quebec Hopital de l Enfant Jesus Québec Quebec
Shandong Cancer Hospital Jinan Shandong
West China Hospital of Sichuan University Chengdu Sichuan
Fujian Cancer Hospital Fuzhou China
Institut Bergonie Bordeaux France
Centre Leon Berard Lyon France
Institut Universitaire du Cancer Toulouse Oncopole Toulouse France
Gustave Roussy Villejuif France
Universitaetsklinikum Essen Essen Germany
Henry Dunant Hospital Center Athens Greece
Alexandra Hospital Athens Greece
European Interbalkan Medical Center Thessaloniki Greece
Iatriko Diavalkaniko Thessalonikis Thessaloniki Greece
Semmelweis Egyetem Budapest Hungary
Clinexpert Kft Bugat Pal Korhaz Gyöngyös Hungary
Istituto di Candiolo Fondazione del Piemonte per l Oncologia IRCCS Candiolo to Italy
Istituto Romagnolo per lo Studio dei Tumori Dino Amadori Meldola (FC) Italy
Azienda Socio Sanitaria Territoriale Grande Ospedale Metropolitano Niguarda Milan Italy
Seoul National University Hospital Seoul South Korea
Severance Hospital Yonsei University Health System Seoul South Korea
Asan Medical Center Seoul South Korea
Hospital Universitari Vall d Hebron Barcelona Catalonia
Hospital de la Santa Creu i Sant Pau Barcelona Catalonia
Hospital Universitario Puerta de Hierro Majadahonda Majadahonda Madrid
Hospital Universitario 12 de Octubre Madrid Spain

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06898957 on ClinicalTrials.gov ↗ ← All trials in the USA